Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder
Summary
The purpose of this study is to evaluate the safety and efficacy of F2695 sustained release (SR) relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).
Description
Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with F2695 SR are randomized to continue F2695 SR or switch to placebo under double-blind conditions for up to 24 weeks of additional treatment.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Intervention
F2695 SR, Placebo
Location
Forest Investigative Site #023
Beverly Hills
California
United States
90210
Status
Recruiting
Source
Forest Laboratories
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01085812
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-24T14:06:54-0400
Clinical Trials
Safety and Efficacy of F2695 SR in Major Depressive Disorder
The purpose of this study is to evaluate the efficacy, safety, and tolerability of F2695 SR fixed doses versus placebo in the treatment of outpatients with major depressive disorder.
Effect of F2695 on Brain Activity Measured by Functional Magnetic Resonance Imaging
The aim of this functional Magnetic Resonance Imaging (MRI) study is to assess the effect of single dose of F2695 at 75mg on modulation of the cerebral motor network.
Safety and Efficacy of F2695 SR in Major Depressive Disorder
The purpose of this study is to evaluate the efficacy, safety, and tolerability of F2695 SR versus placebo in the treatment of outpatients with major depressive disorder.
Safety and Efficacy of F2695 SR in Major Depressive Disorder
The purpose of this study is to evaluate the efficacy, safety, and tolerability of F2695 SR versus placebo in the treatment of outpatients with major depressive disorder
Safety Study of F2695 SR in Major Depressive Disorder
The purpose of this study is to evaluate the long- term safety of F2695-SR in the treatment of adults with major depressive disorder.
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Medical and Biotech [MESH] Definitions
Decompression
Decompression external to the body, most often the slow lessening of external pressure on the whole body (especially in caisson workers, deep sea divers, and persons who ascend to great heights) to prevent DECOMPRESSION SICKNESS. It includes also sudden accidental decompression, but not surgical (local) decompression or decompression applied through body openings.
Depression, Postpartum
Depression in POSTPARTUM WOMEN, usually within four weeks after giving birth (PARTURITION). The degree of depression ranges from mild transient depression to neurotic or psychotic depressive disorders. (From DSM-IV, p386)
Depression
Depressive states usually of moderate intensity in contrast with major depression present in neurotic and psychotic disorders.
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Imipramine
The prototypical tricyclic antidepressant. It has been used in major depression, dysthymia, bipolar depression, attention-deficit disorders, agoraphobia, and panic disorders. It has less sedative effect than some other members of this therapeutic group.
